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The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

NCT02495662 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-09-18

No results posted yet for this study

Summary

This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.

Conditions

  • Renal Dialysis
  • Hemodynamics
  • Vascular Remodeling
  • Neointima

Interventions

DRUG

PEG-liposomal prednisolone sodium phosphate

Liposomal prednisolone

DRUG

Placebo

0.9% normal saline

Sponsors & Collaborators

  • HagaZiekenhuis

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • OLVG

    collaborator NETWORK

  • Medical Center Haaglanden

    collaborator OTHER

  • Reinier de Graaf Groep

    collaborator OTHER

  • Spaarne Gasthuis

    collaborator OTHER

  • Alrijne Hospital

    collaborator OTHER

  • Tergooi Ziekenhuis

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Joris I Rotmans, MD PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-05-30
Completion
2018-05-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495662 on ClinicalTrials.gov